LEXINGTON, Mass., Aug. 8, 2019 /PRNewswire/ -- Agenus Inc. (NASDAQ:
AGEN), an immuno-oncology (I-O) company with a pipeline of immune
checkpoint antibodies, adoptive cell therapies1, and
cancer vaccines provided corporate updates and reported financial
results for the second quarter of 2019.
"In the second quarter our progress continued at a rapid pace,"
said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "This
year we delivered 2 INDs, initiated the interim analysis in our
CTLA-4 & PD-1 trials, triggered cash milestones in our Gilead
collaboration, advanced our next generation CTLA-4 in the clinic,
and brought on board our head of commercial operations. We look
forward to discussing all of these in more detail during our call
and at our global R&D days in the next few months."
- Achievements
-
- Delivered on partnership programs; triggering additional
cash milestones
-
- Triggered $15 million from Gilead
as milestone payment for IND acceptance of AGEN1423 (now GS-1423)
& AGEN2373
- CTLA-4 and PD-1 trials advancing – interim analysis
underway
-
- Trials in 2L cervical cancer designed to support BLA via
accelerated pathway
- Interim analysis underway; data readouts expected 2H2019
- PD-1 market expansion planned through project-based
financing
- Enrollment proceeding in next-gen CTLA-4 trial
-
- Clinical trial underway; combinations and early data expected
this year
- Advanced new discoveries towards the clinic
-
- AGEN2373 IND accepted by FDA
- Off-the shelf phosphorylated neoantigen vaccine advanced to
IND
- QS-21 Updates
-
- Sales of Shingrix, containing our QS-21 Stimulon™, continue to
increase; GSK projects 2019 sales will exceed $1.3Bn
- AgenTus Cell Therapy Business:
-
- IND for allogeneic cell therapy on track for 2H2019
- IND for autologous NYESO-1 planned for 2H2019; proprietary
combinations with Agenus check point antibodies planned in
1H2020
- Partnership and private financing discussions are underway
Second Quarter 2019 Financial Results
We ended the second quarter of 2019 with a cash balance of
$122 million as compared to
$53 million at December 31,
2018.
For the six months ended June 30,
2019, we reported a net loss of $34
million or $0.24 per share
compared to a net loss for the same period in 2018 of $79 million or $0.76 per share. During the first half of the
year we recognized revenue of $96
million which includes revenue from our transaction with
Gilead and non-cash royalties earned and recorded $20 million of non-cash interest expense due to
our liability related to the sale of future royalties. Our
operating expenses for the first half of 2019 increased by
$29 million as a result of the
advancement of our programs.
For the second quarter ended June 30,
2019, we reported net loss of $52
million or $0.38 per share
compared to a net loss for same period in 2018 of $25 million, or $0.24 per share.
Both periods results include one time and non-cash items.
Conference Call, Webcast and Prepared Statement
Information
Date: Thursday, August 8, 2019
Time: 8:30 a.m. ET
Domestic Dial-in Number: (844) 492-3727
International Dial-in Number: (412) 317-5118
Conference ID: Agenus
Live Webcast: accessible from the Company's website
at http://investor.agenusbio.com/presentation-webcasts or
with this link
https://www.webcaster4.com/Webcast/Page/1556/31262
A replay will be available on the Company's website
approximately two hours after the call and will remain available
for 90 days.
About Agenus
Agenus is a clinical-stage immuno-oncology company focused on
the discovery and development of therapies that engage the body's
immune system to fight cancer. The Company's vision is to expand
the patient populations benefiting from cancer immunotherapy with
combination approaches that leverage a broad repertoire of antibody
therapeutics, adoptive cell therapies (through its AgenTus
Therapeutics subsidiary) and its proprietary cancer vaccine
platforms. Agenus has a suite of antibody discovery platforms and a
state-of-the-art GMP manufacturing facility with the capacity to
support early phase clinical programs. Agenus is headquartered in
Lexington, MA. For more
information, please visit www.agenusbio.com and our twitter handle
@agenus_bio. Information that may be important to investors will be
routinely posted on our website and twitter.
About AgenTus Therapeutics, Inc.
AgenTus Therapeutics, a subsidiary of Agenus, is a
preclinical-stage biopharmaceutical company focused on the
discovery, development, and commercialization of breakthrough
"living drugs" to advance potential cures for cancer
patients. AgenTus employs naturally-derived and engineered
receptors, specifically T cell receptors (TCRs) and Chimeric
Antigen Receptors (CARs), designed to supercharge human immune
effector cells to seek and destroy cancer. AgenTus also aims
to advance adoptive cell therapy formats which would enable
off-the-shelf living drugs. AgenTus has locations
in Lexington, MA and Cambridge, UK. For more
information, please visit www.agentustherapeutics.com.
Forward-Looking Statements
This press release contains forward-looking statements that are
made pursuant to the safe harbor provisions of the federal
securities laws, including statements regarding Agenus and AgenTus'
clinical development and regulatory plans and timelines, expected
timing for releasing clinical data, projected sales for GSK's
Shingrix vaccine, Agenus' plan to expand PD-1 development in
additional indications through novel funding mechanisms,
anticipated IND filings, and partnership and financing plans for
AgenTus. These forward-looking statements are subject to risks and
uncertainties that could cause actual results to differ materially.
These risks and uncertainties include, among others, the factors
described under the Risk Factors section of our most recent
Quarterly Report on Form 10-Q or Annual Report on Form 10-K filed
with the Securities and Exchange Commission. Agenus cautions
investors not to place considerable reliance on the forward-looking
statements contained in this release. These statements speak only
as of the date of this press release, and Agenus undertakes no
obligation to update or revise the statements, other than to the
extent required by law. All forward-looking statements are
expressly qualified in their entirety by this cautionary
statement.
Contact:
Agenus Inc.
Jennifer Buell, PhD
781-674-4420
Jennifer.Buell@agenusbio.com
1 Through AgenTus Therapeutics, a subsidiary of
Agenus
Select Financial
Information
|
|
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|
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(in thousands, except
per share data)
|
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|
|
(unaudited)
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|
|
|
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|
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June 30,
2019
|
|
December 31,
2018
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
$
121,717
|
|
$
53,054
|
|
|
|
|
|
|
|
|
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Three months ended
June 30,
|
|
Six months ended June
30,
|
|
|
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues, research
and development
|
|
$
4,399
|
|
$
10,473
|
|
$
75,271
|
|
$
12,109
|
Revenues, non-cash
royalty
|
|
|
9,263
|
|
5,422
|
|
17,869
|
|
5,422
|
Revenues,
other
|
|
|
|
2,053
|
|
-
|
|
2,468
|
|
-
|
Research and
development expenses
|
|
45,243
|
|
29,274
|
|
85,374
|
|
58,715
|
General,
administrative, and other expenses, net
|
11,945
|
|
12,061
|
|
22,096
|
|
20,066
|
Non-cash interest
expense
|
|
|
10,181
|
|
6,056
|
|
19,609
|
|
8,725
|
Loss on early
extinguishment of debt
|
|
-
|
|
-
|
|
-
|
|
10,767
|
Non-cash contingent
consideration fair value adjustment
|
213
|
|
(6,292)
|
|
2,961
|
|
(1,276)
|
Net loss
|
|
|
|
|
(51,867)
|
|
(25,204)
|
|
(34,432)
|
|
(79,466)
|
Net loss per share
attributable to Agenus Inc. common stockholders
|
$
(0.38)
|
|
$
(0.24)
|
|
$
(0.24)
|
|
$
(0.76)
|
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SOURCE Agenus Inc.